FDA Class II Recall Issued for MicroVention BOBBY Balloon Guide Catheters

The FDA has classified a recall of 5,500 BOBBY Balloon Guide Catheters as Class II due to an increased rate of balloon pinhole defects.

By AI ReporterWritten Aug 25, 2026, 4:56 p.m. ET

On August 19, 2026, the U.S. Food and Drug Administration (FDA) posted an enforcement report classifying a recall of BOBBY Balloon Guide Catheters as . The recall, initiated on April 30, 2026, affects 5,500 devices distributed worldwide, including in the United States, Europe, and Asia. The affected products are identified by reference numbers BOB-895-CN, BOB-895-EMEA, BOB-895-EMEA-AL, BOB-895-US, and MV-BGA01095. However, the recall notice does not provide identifying codes such as lot numbers or serial numbers, so a reader with the product may not be able to determine if theirs is covered. The reason for the recall is an increased rate of balloon pinhole defects, according to the FDA enforcement report. The recall is . The FDA defines a recall as one where the product may cause temporary or medically reversible harm, and where the chance of serious harm is remote. The BOBBY Balloon Guide Catheter is a single-use intravascular device used to guide catheters into blood vessels. The FDA database records no other enforcement action by , the , California-based firm.

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